A Study to Investigate Safety, Tolerability and Pharmacokinetics of LAE103 or LAE103 in Combination With LAE102 in Healthy Overweight/Obese Participants

StatusRecruiting
PhasePhase 1
Started

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Record History

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  1. Notable Primary endpoints: details revised at 1 of 1 entry
    • Interventions modified
    • Trial arms changed: 3 → 4
    • Eligibility criteria expanded, about 90 words
  2. Minor Study sites: 1 to 2
    • Eligibility criteria expanded, about 1,580 words
    • Secondary endpoints: details revised at 5 of 5 entries
    v3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 31, 2025 to Dec 30, 2025
    • Site details revised
    • Study description expanded, about 1 word
    v2
  4. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of LAE103 injection in healthy overweight/obese participants or healthy postmenopausal women. Study will also evaluate the safety, tolerability and preliminary pharmacodynamic effect of multiple dose injections in overweight/obese participants. In addition, the study will also investigate the safety, tolerability of a single-dose co-administration of LAE102 and LAE103 in healthy overweight/obese participants.
Trial Details
NCT Number NCT07230496
Lead Sponsor Laekna Limited
Conditions
(from sponsor)
Overweight and Obesity
Related terms Obesity, Overweight
Enrollment 104 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov